Providing eligibility, efficacy and security evaluation by quantitative and qualitative disease findings, medical imaging
has become increasingly important in clinical trials. Here, subject’s data is today captured in electronic case reports
forms (eCRFs), which are offered by electronic data capture (EDC) systems. However, integration of subject’s medical
image data into eCRFs is insufficiently supported. Neither integration of subject’s digital imaging and communications
in medicine (DICOM) data, nor communication with picture archiving and communication systems (PACS), is possible.
This aggravates the workflow of the study personnel, in special regarding studies with distributed data capture in
multiple sites. Hence, in this work, a system architecture is presented, which connects an EDC system, a PACS and a
DICOM viewer via the web access to DICOM objects (WADO) protocol. The architecture is implemented using the
open source tools OpenClinica, DCM4CHEE and Weasis. The eCRF forms the primary endpoint for the study personnel,
where subject’s image data is stored and retrieved. Background communication with the PACS is completely hidden for
the users. Data privacy and consistency is ensured by automatic de-identification and re-labelling of DICOM data with
context information (e.g. study and subject identifiers), respectively. The system is exemplarily demonstrated in a
clinical trial, where computer tomography (CT) data is de-centrally captured from the subjects and centrally read by a
chief radiologists to decide on inclusion of the subjects in the trial. Errors, latency and costs in the EDC workflow are
reduced, while, a research database is implicitly built up in the background.